Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K203367 |
Device Name |
LineSider™ Spinal System |
Applicant |
Integrity Implants Inc. |
354 Hiatt Drive |
Palm Beach Gardens,
FL
33418
|
|
Applicant Contact |
Lauren Kamer |
Correspondent |
Empirical Testing Corp. |
4628 Northpark Drive |
Colorado Springs,
CO
80918
|
|
Correspondent Contact |
Nathan Wright |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/16/2020 |
Decision Date | 12/03/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|